The following data is part of a premarket notification filed by Olson Medical Sales, Inc. with the FDA for Components For Cardiovascular Procedure Kit - Heat Exchanger Coils.
| Device ID | K000977 |
| 510k Number | K000977 |
| Device Name: | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | OLSON MEDICAL SALES, INC. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Gary A Courtney |
| Correspondent | Gary A Courtney OLSON MEDICAL SALES, INC. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2001-03-23 |